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The UK became the first western country to grant emergency authorisation for a COVID-19 vaccine on Wednesday (2 December). It is the first time a vaccine based on revolutionary messenger RNA technology has ever been approved by a regulator.
The vaccine, developed by Germany’s BioNTech (BNTX) in partnership with US pharma company Pfizer (PFE), was granted approval by the Medicines and Healthcare Regulatory Agency (MHRA), which said its decision was “based on a rolling submission, including data from the Phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95%.”
“Messenger RNA is a new drug entity,” BioNTech co-founder and CEO Ugur Sahin told the media today. “However, it is the first molecule of life, it emerged many billions of years ago and every human and animal has messenger RNA in their cells.”
On a press call with journalists on Wednesday, Özlem Türeci, BioNTech co-founder and chief medical officer, said they were “delighted” with the MHRA approval. |
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发表于 2020-12-2 10:05 AM
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发表于 2020-12-3 01:11 AM
